Document: document 0 change

• document 0
• document 1
• document 2
• document 3
• document 4

---

Erythrocin® 500mg Tablets Erythromycin 500mg Tablets

(erythromycin stearate)

In this leaflet:

1)    What Erythrocin Tablets are and what they are used for

2)    Before you take Erythrocin Tablets

3)    How to take Erythrocin Tablets

4)    Possible side effects

5)    How to store Erythrocin Tablets

6)    Further information

1)    What Erythrocin Tablets are and what they are used for

Erythrocin contains the active ingredient erythromycin which belongs to a

group of medicines called macrolide antibiotics.

Erythrocin Tablets are used to prevent and treat infections such as:

•    Throat and sinus infections.

•    Chest infections, such as bronchitis and pneumonia.

•    Ear infections.

•    Mouth and dental infections.

•    Eye infections.

•    Skin and tissue infections, such as acne.

•    Stomach and intestinal infections.

•    Prevention of infection following burns, operations or dental procedures.

•    Other infections, such as sexually transmitted diseases, bone infections or scarlet fever.

2)    Before you take Erythrocin Tablets

You should not receive Erythrocin Tablets if you:

•    have been told that you are allergic to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin or any of the other ingredients in these tablets.

•    are taking ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects.

•    are taking terfenadine or astemizole (widely taken for hayfever and allergies), cisapride (for stomach disorders) or pimozide (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead.

•    are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects.

•    have any liver problems or have been told that any drugs you are taking can cause liver problems

•    have previously experienced diarrhoea following the use of antibiotics;

•    are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and your child is under 1 year and is prescribed erthyromycin, consult your doctor before giving erythromycin to your child.

•    are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.

•    suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin.

•    are taking erythromycin with ‘statins' such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur

If any of these apply to you, or if you are not sure, tell your doctor.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken any other medicines, including any medicines obtained without a prescription.

This is especially important if you are taking medicines from the following families:

•    astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever);

•    pimozide (used to treat mental problems);

•    ergotamine or dihydroergotamine (used to relieve migraine);

•    cisapride (used to treat stomach disorders);

•    statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin);

•    protease inhibitors (used to treat viral infections e.g. saquinavir);

•    oral contraceptives.

This is also important if you are taking medicines called:

•    colchicine (used to treat gout and arthritis);

•    cimetidine and omeprazole (used to treat acid reflux and other related conditions);

•    clarithromycin, rifabutin, or rifampicin (medicines used to treat different types of bacterial infection);

•    fluconazole, ketoconazole and itraconazole (medicines used to treat fungal infections);

•    digoxin, quinidine or disopyramide (used to treat heart problems);

•    cilostazol (a medicine used to treat peripheral circulation problems);

•    hexobarbitone, phenobarbital or midazolam (used as sedatives);

•    warfarin and acenocoumarol (used to help thin the blood);

•    valproate, carbamazepine or phenytoin (used to control epilepsy);

•    theophylline (used to treat asthma and other breathing problems);

•    ciclosporin or tacrolimus (used following organ transplants);

•    bromocriptine (used to treat Parkinson's disease);

•    zopiclone or triazolam/alprazolam (used to help you sleep or relieve states of anxiety);

•    alfentanil (a medicine used to provide pain relief);

•    methylprednisolone (used to help suppress the body's immune system -this is useful in treating a wide range of conditions);

•    St John's Wort (a herbal medicine used to treat depression);

•    verapamil (used to treat high blood pressure and chest pain);

•    vinblastine (used to treat certain types of cancer);

•    sildenafil (used to treat erectile dysfunction).

If you or your child goes for any medical tests, tell your doctor that you are taking Erythrocin Tablets, as this may interfere with some test results.

Pregnancy and breast-feeding

Erythromycin should be used by women during pregnancy only if clearly needed.

If you are pregnant or think you may be pregnant, or if you are breast-feeding, please consult your doctor before taking this medicine.

3)    How to take Erythrocin Tablets

Always take Erythrocin Tablets exactly as your doctor has told you.

You should check with your doctor if you are not sure.

The usual dose of Erythrocin Tablets for adults and children over 8 years is:

1-2 g daily in divided doses i.e. four to eight 250 mg tablets daily or two to four 500 mg tablets daily, taken just before or with meals or food. If you have a bad infection you may be told to take up to 4 g daily.

Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back.

If you take more Erythrocin Tablets than you should

If you accidentally take more medicine in one day than your doctor has told you to, or if a child has taken some of the medicine by mistake, contact your doctor or go to your nearest hospital emergency department immediately. An overdose of Erythrocin could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythrocin Tablets

If you forget to take a dose of your medicine, take it as soon as you remember. Do not take more medicine in one day than your doctor tells you to.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4)    Possible side effects

Like all medicines, Erythrocin Tablets can cause side effects, although not everybody gets them.

If you notice any of the following, contact your doctor immediately:

•    difficulty breathing;

•    fainting;

•    swelling of the face, lips or throat;

•    skin rashes;

•    severe skin reactions including large fluid-filled blisters, sores and ulcers;

•    ulcers in the mouth and throat;

as these may be signs of an allergic reaction.

Other side effects of Erythrocin include:

•    diarrhoea which may be severe or prolonged and may contain blood or mucus;

•    feeling sick or being sick

•    increase in a particular type of white blood cells (eosinophilia);

•    stomach pains; these may be a symptom of an inflamed pancreas (pancreatitis);

•    ringing in the ears (tinnitus);

•    reversible loss of hearing (usually associated with high doses or in patients with kidney problems);

•    various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine;

•    chest pains;

•    abnormal heart rhythms (including palpitations);

•    fever;

•    anorexia;

•    confusion;

•    fits (seizures);

•    vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly on standing);

•    hallucinations (seeing or hearing things that aren't there);

•    feeling generally unwell (malaise);

•    inflammation of the kidneys (a condition known as interstitial nephritis);

•    low blood pressure;

•    serious skin rashes that may involve blistering and can cover large areas of the torso, face and limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5)    How to store Erythrocin Tablets

•    Keep all medicines out of the sight and reach of children.

•    Do not take your tablets after the expiry date printed on the carton, or blister label. The expiry date refers to the last day of that month

•    Do not store above 30°C. Protected from light.

•    If the tablets become discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6)    Further information

What Erythrocin Tablets contains:

Each film-coated tablet contains 500mg of the active ingredient erythromycin as the stearate.

Erythrocin Tablets also contain the following ingredients: magnesium hydroxide, povidone, maize starch, polacrilin potassium, hydroxypropylmethylcellulose, polyethylene glycol 400 & 8000.

What Erythrocin Tablets looks like and contents of the pack

Erythrocin Tablets are white, film-coated, capsule-shaped and plain on both sides.

Erythrocin Tablets are available as blister packs of 12 tablets.

PL 10383/0691    |POM

Who makes and repackages your medicine?

Your medicine is manufactured by Farmar ABEE, Attikis, Greece. Procured from within the EU and repackaged by Product Licence Holder Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 28.02.2013

Erythrocin Tablets® is a trade mark of Abbott Laboratories, Abbott Park,

Illinois, USA.